Follitropin Alfa

Gonal-f® (follitropin alfa for injection) is supplied in a sterile, lyophilized form in multiple dose vials filled with 600 IU or 1200 IU in order to deliver 450 IU and 1050 IU FSH, respectively, after reconstitution with diluent (Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol as a preservative). Each carton contains syringes with mounted 27G × 0.5 inch needle, calibrated in FSH units (IU FSH) which should be used for administration. Lyophilized Multi-Dose vials may be stored refrigerated or at room temperature (2°-25°C/36°-77°F). Following reconstitution, the Multi-Dose vial may be stored refrigerated or at room temperature (2°-25°C/36°-77°F). Protect from light. Discard unused reconstituted solution after 28 days.

The following package combinations are available:

• 1 vial Gonal-f® Multi-Dose 450 IU, 1 pre-filled syringe of Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), 1 mL and 6 syringes calibrated in FSH Units (IU FSH) for injection NDC 44087-9030-1
• 1 vial Gonal-f® Multi-Dose 1050 IU, 1 pre-filled syringe of Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), 2 mL and 10 syringes calibrated in FSH Units (IU FSH) for injection NDC 44087-9070-1

Manufactured for: EMD Serono, Inc., Rockland, MA 02370 U.S.A. Revised: Apr 2013

Follitropin Alfa is part of the drug class:

• Gonadotropins

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Upset stomach.
• Pimples (acne).
• Headache.
• Belly pain.
• Gas.
• Loose stools (diarrhea).
• Feeling tired or weak.
• Nose or throat irritation.
• Back pain.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store in a refrigerator or at room temperature.
• Do not freeze.
• Protect from light.
• Be sure you know how long you can store this medicine before you need to throw it away.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• Follicle Stimulating Hormone, Recombinant
• FSH
• rFSH-alpha
• rhFSH-alpha

• Gonal-f
• Gonal-f RFF
• Gonal-f RFF Pen [DSC]
• Gonal-f RFF Rediject

• Gonadotropin
• Ovulation Stimulator

There are no dosage adjustment provided in the manufacturer's labeling (has not been studied).

Gonal-f: Store powder refrigerated or at room temperature of 2°C to 25°C (36°F to 77°F). Protect from light; do not freeze. Following reconstitution, multidose vials may be stored under refrigeration or at room temperature for up to 28 days.

Gonal-f RFF:

Powder: Store at room temperature or under refrigeration of 2°C to 25°C (36°F to 77°F). Protect from light. Discard unused drug.

Solution (pen): Prior to dispensing, store under refrigeration at 2°C to 8°C (36°F to 46°F). Upon dispensing, patient may store under refrigeration until product expiration date or at room temperature of 20°C to 25°C (68°F to 77°F) for up to 3 months. Do not freeze. Protect from light. After first use, store pen in the refrigerator (2°C to 8°C [36°C to 46°F]) or at room temperature (20°C to 25°C [68°F to 77°F]); discard unused portion after 28 days.

Percentage may vary by indication, product formulation

>10%:

Cardiovascular: Varicocele (15%)

Central nervous system: Headache (13% to 27%)

Dermatologic: Acne vulgaris (males 59%)

Endocrine & metabolic: Ovarian cyst (4% to 15%)

Gastrointestinal: Abdominal pain (9% to 23%), nausea (4% to 14%), enlargement of abdomen (1% to 14%)

Genitourinary: Mastalgia (males 14%)

Local: Injection site reaction (males 15%; females 1% to 4%),

Respiratory: Upper respiratory tract infection (4% to 12%)

1% to 10%:

Cardiovascular: Chest pain (1% to 2%), hypotension (1% to 2%), palpitations (1% to 2%)

Central nervous system: Fatigue (males 9%; females 1% to 2%), pain (2% to 6%), emotional lability (5%), migraine (1% to 4%), dizziness (1% to 3%), malaise (2%), anxiety (1% to 2%), drowsiness (1% to 2%), nervousness (1% to 2%), paresthesia (1% to 2%)

Dermatologic: Acne vulgaris (females 4%), pruritus (1% to 2%)

Endocrine & metabolic: Gynecomastia (9%), intermenstrual bleeding (4% to 9%), ovarian hyperstimulation syndrome (5% to 7%; severe: <1%), weight gain (4%), menstrual disease (3%), hot flash (2%), ovarian disease (2%), increased thirst (1% to 2%)

Gastrointestinal: Diarrhea (1% to 8%), flatulence (4% to 7%), toothache (1% to 4%), vomiting (1% to 3%), aphthous stomatitis (2%), constipation (2%), dyspepsia (2%), anorexia (1% to 2%)

Genitourinary: Pelvic pain (7%), mastalgia (females 4% to 6%), vaginal hemorrhage (1% to 6%), cervical lesion (3%), genital candidiasis (3%), dysmenorrhea (1% to 3%), cystitis (2%), gynecological pain (2%), urinary frequency (2%), urinary tract infection (2%), uterine hemorrhage (2%), leukorrhea (1% to 2%)

Infection: Viral infection (2%)

Local: Bruising at injection site (10%), pain at injection site (3% to 9%), inflammation at injection site (1% to 4%), swelling at injection site (3%)

Neuromuscular & skeletal: Back pain (4% to 5%), myalgia (1% to 2%)

Respiratory: Rhinitis (≤7%), pharyngitis (3% to 7%), sinusitis (5% to 6%), flu-like symptoms (4%), cough (2% to 3%), asthma (1% to 2%), dyspnea (1% to 2%)

Miscellaneous: Fever (2% to 4%)

Postmarketing and/or case reports (Limited to important or life-threatening): Anaphylactoid reaction, anaphylaxis, depression, Epstein-Barr infection, hemoperitoneum, hemoptysis, hypersensitivity reaction, ovarian neoplasm, ovarian torsion, ovary enlargement, pulmonary complications (including atelectasis, acute respiratory distress syndrome, exacerbation of asthma), thromboembolism, vascular disease